Senior Biostatistician - Home Based (SA)
On-siteJohannesburg, Gauteng, South Africa or Cape Town, Western Cape, South Africa
Johannesburg, Gauteng, South Africa or Cape Town, Western Cape, South AfricaOn-siteFull TimeSenior LevelPharmaceuticalMedium
Full TimeSenior LevelMediumPharmaceutical
Job Summary
Create randomization and kit schedules independently while collaborating with sponsor and supply management teams. Develop phase 1-4 SAPs, create TLFs shells, and review ADAM data to resolve comments with programmers. Perform sample size calculations, lead projects across all phases, and manage client meetings and CRMs. Review statistical sections of sponsor protocols, provide feedback on study design, and prepare CSR sections with minimal support. Present unblinded output to Data Safety Monitoring Boards and guide others in biostatistical techniques.
Required Qualifications
- College graduate in Biostatistics, Statistics, or Mathematics discipline or related field
- Minimum of 5 years' experience in Biostatistics or similar field
- Expert knowledge of scientific principles and concepts
- High level knowledge of drug development as it pertains to biostatistics
- Ability to apply drug development knowledge during production of high quality statistical analyses
- Strong SAS programming, SAS base, SAS macro experience
- Thorough knowledge and understanding of clinical data
- Strong experience with data and production of TLGs
- Excellent scientific writing skills
- Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques
- Proficiency with MS Office applications
- Hands-on experience with clinical trial and pharmaceutical development
- Good communication skills and willingness to work with others to clearly understand needs and solve problems
- Excellent problem-solving skills
- Good organizational and communication skills
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements
- Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process
Desired Qualifications
- Masters or PhD preferred
- Many years of related experience required
- Thorough knowledge and understanding of clinical data preferred
- Hands-on experience with clinical trial and pharmaceutical development preferred
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